Singular Health has submitted a 510(k) premarket notification to the US Food and Drug Administration (FDA) for its ...
In this interview, Kalpana Barnes highlights how new approach methodologies are addressing the gaps in drug discovery studies ...
Medicus Pharma Ltd. (NASDAQ: MDCX) has submitted a federal priority-review request for its investigational SkinJect microneedle patch, a dissolvable doxorubicin-based therapy designed to ...
Scholars argue that federal drug agency actions should take precedence over conflicting state regulations. How should courts handle state regulations that restrict access to pharmaceuticals previously ...
Richard Pazdur, the new director of the Center for Drug Evaluation and Research, raised concerns amid the rollout of several ...
The U.S. Food and Drug Administration on Tuesday extended its review of Ascendis Pharma's therapy for children with a rare ...
An FDA officer explains the agency’s compliance requirements for importing pharmaceuticals and biologics and processes.
Blackbaud , the leader in AI for social impact, kicked off its bi-annual Product Update Briefings last week, highlighting recent innovation and future roadmap direction for Blackbaud's suite of ...
The convergence of genomics, systems biology, and artificial intelligence is transforming the landscape of drug discovery. Modern genomic technologies now ...